Device Validation of Augmented-Reality ICG Fluorescence Imaging for Sentinel Lymph Node Detection in Breast Cancer

Официальное название

Validation of Augmented-Reality/Virtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer

Обзор

This study evaluates how accurately augmented-reality goggles with indocyanine green (ICG) near-infrared fluorescence can identify sentinel (first-draining) lymph nodes during breast cancer surgery. The goggles and ICG signal are used to mark candidate sentinel nodes, and an additional observer may record near-infrared images during the operation for device-performance assessment. These imaging findings do not change the surgical procedure. The candidate nodes and all removed tissue are examined by histopathology, which serves as the reference standard. Two hundred patients undergoing breast cancer surgery will take part. The study measures how well the goggle-based imaging detects nodes that contain cancer, compared with final pathology.

Подробное описание

This is a prospective observational device-validation study in patients undergoing breast cancer surgery with axillary evaluation. Augmented-reality goggle-based near-infrared fluorescence imaging with ICG is used to visualize and mark candidate sentinel lymph nodes. Intraoperative near-infrared imaging may be performed by an observer who is not the operating surgeon, solely to assess device performance; observer findings are not communicated to the operating surgeon before wound closure and do not influence the operation. All marked nodes and removed tissue undergo histopathology, which serves as the blinded reference standard. Device performance is assessed on consecutive eligible patients within defined enrollment windows; for each near-infrared imaging device, sensitivity, specificity, positive and negative predictive value, and node-level ROC analysis are estimated against final histopathology, with confidence intervals accounting for clustering of nodes within patients. The study is non-interventional: the imaging does not alter surgical management.

Вмешательства

• Устройство AR-ICG near-infrared fluorescence imaging
  Augmented-reality goggle-based near-infrared fluorescence imaging with indocyanine green (ICG), used to visualize and mark candidate sentinel lymph nodes during breast cancer surgery. Intraoperative near-infrared imaging may also be recorded by an observer for device-performance assessment. Imaging does not alter surgical management; histopathology serves as the reference standard.

Первичные конечные точки

• Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology [Срок оценки: From surgery to final histopathology (up to ~2 weeks after surgery)]

Вторичные конечные точки (5)

• Patient-level sentinel-node detection rate [Срок оценки: Final histopathology (up to approximately 2 weeks after surgery)]
• Concordance of device-marked nodes with histopathology [Срок оценки: Final histopathology (up to approximately 2 weeks after surgery)]
• Per-device diagnostic performance across near-infrared imaging systems [Срок оценки: Through study completion (up to approximately 24 months)]
• False-negative rate of AR-ICG fluorescence node detection [Срок оценки: Final histopathology (up to approximately 2 weeks after surgery)]
• Number of candidate sentinel nodes identified per patient [Срок оценки: Intraoperative (day of surgery)]

Критерии участия

Критерии включения

• Histologically proven breast cancer
• Age 18 years or older
• Undergoing breast cancer surgery with sentinel lymph node evaluation and/or axillary lymph node dissection
• Provides written informed consent

Критерии исключения

• Pregnancy
• Neoadjuvant chemotherapy
• Prior breast surgery
• Iodine or seafood allergy
• Indocyanine green (ICG) allergy
• Declines or is unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

North Macedonia · 1 центр

• University Clinic for Thoracic and Vascular Surgery, Faculty of Medicine, UKIM — Skopje

Публикации

• Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918- PMID 28898379
• Xiong X, Zheng LW, Ding Y, Chen YF, Cai YW, Wang LP, Huang L, Liu CC, Shao ZM, Yu KD. Breast cancer: pathogenesis and treatments. Signal Transduct Target Ther. 2025 Feb 19;10(1):49. doi: 10.1038/s41392-024-02108-4. PMID 39966355
• Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery PMID 25439688
• de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialis PMID 38598571

Идентификаторы

NCT: NCT07683572 · UKIM-AR-ICG-BREAST-VALID-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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